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Article

Loeb & Loeb LLP | USA | 30 Apr 2019

FDA Regulatory and Compliance Monthly Recap April 2019

The guidance describes what pediatric information should be included in the labeling of drugs and biologics and where it should be located to make it

Article

Riker Danzig Scherer Hyland & Perretti LLP | USA | 8 Apr 2019

Riker Danzig Health Care Update April 8, 2019

New Jersey State: Selected Proposed and Adopted Legislation

Article

Robinson & Cole LLP | USA | 8 Apr 2019

CBD Update: FDA Issues Statement, Calls Public Hearing, and Announces Warning Letters on Products Containing Cannabis and its Components

On April 2, 2019, the Federal Food and Drug Administration (FDA) issued a statement and announced a public hearing on consumer products derived from

Article

Hall Render Killian Heath & Lyman PC | USA | 5 Apr 2019

Hall Render’s This Week in Washington - April 5, 2019

Speaking on the Senate floor on Thursday, Sen. Lamar Alexander (R-TN), Chairman of the Health, Education, Labor, and Pensions (“HELP”) Committee

Article

Haynes and Boone LLP | USA | 29 Mar 2019

It’s All in the Name: Updated FDA Guidance on Nonproprietary Naming of Biologic Products

In January 2017, the FDA published guidance that adopted a naming convention that attaches a distinguishing suffix to the proper names of both

Article

Finnegan, Henderson, Farabow, Garrett & Dunner LLP | USA | 19 Mar 2019

FDA Final Guidance on the Nonproprietary Naming of Biological Products: Update

On March 7, 2019, FDA issued draft guidance that describes FDA’s current thinking on nonproprietary names of biological products licensed under

Article

Rothwell, Figg, Ernst & Manbeck, PC | USA | 17 Mar 2019

Biosimilars Will Get Special Names- Suffixes Are Here to Stay

Announcing that it will create special names for biosimilar products to distinguish them from previously approved biologic products

Article

Baker & Hostetler LLP | USA | 12 Mar 2019

FDA and Pharmacy Weekly Digest - March 12

FDA Commissioner Announces Resignation - Food and Drug Administration Commissioner Scott Gottlieb announced his resignation, citing personal reasons

Article

Riker Danzig Scherer Hyland & Perretti LLP | USA | 11 Mar 2019

Riker Danzig Health Care Update March 11, 2019

New Jersey State: Selected Proposed and Adopted Legislation

Article

Epstein Becker Green | USA | 26 Feb 2019

FDA Finalizes Two Guidance Documents Regarding Regenerative Medicine Therapies

On February 15, 2019, the U.S. Food and Drug Administration (“FDA”) finalized two guidance documents regarding regenerative medicine therapies (see

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